Vioxx

[Rofecoxib]

Indications & Dosage
*IMPORTANT! On Sept. 30, 2004 Merck & Co., Inc. announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib). Please be aware that the information below is provided only for reference.

INDICATIONS AND USAGE

VIOXX (rofecoxib tablets and oral suspension)

Text Continues Below

---

VIOXX is indicated:

For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis in adults. For the management of acute pain in adults. For the treatment of primary dysmenorrhea.

DOSAGE AND ADMINISTRATION

VIOXX is administered orally. The lowest dose of VIOXX should be sought for each patient.

Osteoarthritis

The recommended starting dose of VIOXX is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. The maximum recommended daily dose is 25 mg.

Rheumatoid Arthritis

The recommended dose is 25 mg once daily. The maximum recommended daily dose is 25 mg. Management of Acute Pain and Treatment of Primary Dysmenorrhea The recommended dose of VIOXX is 50 mg once daily. The maximum recommended daily dose is 50 mg. Use of VIOXX for more than 5 days in management of pain has not been studied. Chronic use of VIOXX 50 mg daily is not recommended. (See ADVERSE REACTIONS, Clinical Studies in OA and RA with VIOXX 50 mg).

Hepatic Insufficiency

Because of significant increases in both AUC and Cmax in patients with moderate hepatic impairment (Child-Pugh score: 7-9), the maximum recommended chronic daily dose is 12.5 mg. (See CLINICAL PHARMACOLOGY, Special Populations). The efficacy of 12.5 mg in rheumatoid arthritis patients with moderate hepatic insufficiency has not been studied. VIOXX Tablets may be taken with or without food.

Oral Suspension

VIOXX Oral Suspension 12.5 mg/ 5 mL or 25 mg/ 5 mL may be substituted for VIOXX Tablets 12.5 or 25 mg, respectively, in any of the above indications. Shake before using.

Page:  1 | 2 | Next >>